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Dubbel-blind, gerandomiseerd onderzoek naar nilotinib bij spondyloartritis.


- candidate number9292
- NTR NumberNTR2834
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mrt-2011
- Secondary IDs10/305 MEC AMC
- Public TitleDubbel-blind, gerandomiseerd onderzoek naar nilotinib bij spondyloartritis.
- Scientific TitleProof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis.
- ACRONYMNilotinib
- hypothesisRecently is an altered synovial fibroblast phenotype in SpA versus RA synovium revealed and currently is the role of PDGF in this process confirmed. PDGF-R, c-kit, and c-Fms are all tyrosine kinase receptors which can be blocked by tyrosine kinase inhibitors such as imatinib and nilotinib.
- Healt Condition(s) or Problem(s) studiedSpondyloarthritis
- Inclusion criteria1. Patients should be able and willing to give written informed consent and comply with the requirements of the study protocol;
2. Patients should be between 18 and 65 years of age;
3. Patients must have a diagnosis of spondyloarthritis according to the ESSG criteria;
4. The patient must have an active disease as defined by a patient global assessment of disease activity VAS of > 4 AND a physician global assessment of disease activity VAS of > 4 AND > 1 swollen and > 1 tender joints in case of peripheral disease AND/OR a BASDAI of > 4 in case of axial disease;
5. Patients should have an inadequate response to at least one NSAID at the maximal tolerated dose;
6. The use of concomitant NSAIDs and corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent ≤ 10 mg/day and must be stable for at least 4 weeks prior to baseline. The dose of concomitant NSAIDs and corticosteroids should be kept stable during the whole study period;
7. The use of concomitant DMARDs (methotrexate, sulphasalazine, or leflunomide) is allowed. If using DMARDs, patients must have received a minimum of 3 months of therapy and be on a stable dose for at least 4 weeks prior to baseline. The DMARDs should be kept stable during the study period;
8. Patients of reproductive potential (males and females) must use reliable methods of contraception (e.g. contraceptive pill, IUD, physical barrier) during the whole study until 150 days post-study;
9. Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest X-ray and ECG. In case of use of co-medication which can cause QT-prolongation, extra caution will be made.
- Exclusion criteria1. Patient has a significant comorbidity, including a cardiac, renal, hepatic, neurological, metabolic or any other disease, including ECG alterations, hypokalemia, and hypomagnesemia, that may affect his/her participation in this study;
2. Patient has a recent history of (or persistent) infection requiring hospitalization or antibiotic treatment within 4 weeks of baseline;
3. Patient has active tuberculosis. A PPD test and chest X-ray at screening should be negative (in case of latent tuberculosis, a patient may enter the study if prophylaxis with isoniazide is begun prior to administration of nilotinib). If a patient has an adequately treated active tuberculosis in the past he/she may enter the trial;
4. Patient has previously failed anti-TNF therapy or any other biological agent;
5. Patient has received an intra-articular injection with corticosteroids within 4 weeks prior to baseline;
6. Patient has an active articular disease other than spondyloarthritis that could interfere with the assessment of spondyloarthritis;
7. Patient has an active or recent malignancy (other than basal cell carcinoma of the skin);
8. If female, patient should not be pregnant or breast-feeding. A urine pregnancy-test will be performed at screening and has to be negative;
9. Patient uses concomitant medication which inhibit or induce CYP3A4, such as ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, telithromycin, rifampicin, phenytoin, carbamazepine, phenobarbital and St. John's Wort;
10. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate1-mei-2012
- Target number of participants30
- Interventions1. Nilotinib (Tasigna ) or matching placebo capsules (50% chance);
2. Athroscopy when arthritis.
Patients will receive 400 mg Nilotinib twice a day. After three months, all patients will receive this dose (open label phase).
- Primary outcome1. Patient global assessment of disease activity VAS at week 12;
2. Physician global assessment of disease activity VAS at week 12;
3. Safety and tolerability over 24 weeks.
- Secondary outcome1. Patient global assessment of disease activity VAS at week 24;
2. Physician global assessment of disease activity VAS at week 24;
3. ASAS20 response at week 12 and 24;
4. ASDAS response at week 12 and 24.
- TimepointsVisit 0 = screening (-28 to -1 days);
Visit 1 = week 0;
Visit 2 = week 2;
Visit 3 = week 4;
Visit 4 = week 6;
Visit 5 = week 8;
Visit 6 = week 12;
Visit 7 = week 14;
Visit 8 = week 16;
Visit 9 = week 18;
Visit 10 = week 20;
Visit 11 = week 24.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. D.L. Baeten
- CONTACT for SCIENTIFIC QUERIESDr. D.L. Baeten
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryCountry of recruitment: The Netherlands.
- Main changes (audit trail)
- RECORD31-mrt-2011 - 20-jan-2013


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